Medical product dispensing systems and methods

ABSTRACT

Methods and systems for transferring restricted distribution medical products to an over-the-counter general sales environment are provided. Methods and systems of dispensing non-prescription, behind-the-counter medical products from a vending machine in a general sales location are also provided. In some embodiments, methods and systems are provided for dispensing a medical product from a vending machine in a general sales location based, at least in part, on biometric data collected from the purchaser and, in some instances, based on self-selection and/or de-selection criteria, is provided. Further, methods and systems of switching prescription medical products to non-prescription, over-the-counter medical products are provided.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.12/265,888, filed Nov. 6, 2008 which, in turn, claims the priority toand the benefit of U.S. Provisional Application Ser. No. 61/002,360,filed Nov. 8, 2007 and U.S. Provisional Application Ser. No. 61/068,909,filed Mar. 11, 2008, the contents of all of which are incorporated byreference herein in their entirety.

BACKGROUND OF THE DISCLOSURE

1. Field of the Invention

The present disclosure relates to medicines, nutraceuticals, and medicaldevices (hereinafter collectively referred to as “medical products”)dispensing systems and methods. More particularly, the presentdisclosure relates to systems and methods for dispensing medicalproducts from a vending machine using a self-selection algorithm and, insome embodiments, a de-selection algorithm, which eliminate the need forinteraction between the purchaser and a licensed practitioner. Further,the present disclosure relates to methods of providing a risk managementtool for switching prescription medical products to non-prescription,over-the-counter status. Still further, the present disclosure relatesto systems and methods that provide greater access to over-the-countermedical products that have sales or distribution restrictions due topublic safety and/or public health concerns.

2. Description of Related Art

Drugs, vaccines, biologics, and pharmaceutical products (hereinafterindividually and collectively referred to as “medicines”) are commonlyused to cure, treat and/or mitigate a variety of human and animalailments and maladies. For purposes of dispensing these products in theUnited States, medicines are generally divided by Section 503(b) (1) ofthe Food, Drug, and Cosmetic Act into two classifications, namelyprescription classification and a non-prescription classification. Morespecifically, the Food and Drug Administration (FDA) requires aprescription for the dispensing of any drug that is not safe for useexcept under the supervision of a practitioner licensed by law toadminister such drug. Thus, the FDA can designate a medicine with a nonprescription status when the FDA finds that prescription dispensing isnot necessary for the protection of the public health by reason of thedrug's toxicity or other potentiality for harmful effect, or the methodof its use, or the collateral measures necessary to its use, and thedrug is safe and effective for use in self-medication as directed inproposed labeling.

Due to the highly regulated nature of medicines in the prescriptionclassification, these prescription medicines are mostly dispensed from alicensed pharmacy. Typically, the medicines are controlled and stored ina restricted area of a pharmacy, namely behind-the-counter in thepharmacy, such that the dispensing of the medicine from a pharmacy canonly be performed by or under the supervision of a pharmacist(hereinafter referred to as a “licensed practitioner”).

In contrast, and due to evidence that suggests that there are adequatecontrols and labeling in place for the safe and effective use in anover-the-counter setting, prescription medicines have typically beenmoved over-the-counter (OTC) from the restricted sales area and into thegeneral sales areas in the pharmacy or other retail general saleslocation. As used herein, the term “general sales” area or locationshall mean any area where access to the medicine is not restricted. Assuch, the general sales area or location can include the areas inside ofa store, but not behind-the-counter of the pharmacy orbehind-the-counter of the point-of-sale, and can include areas outsideof the store.

In addition to the regulations placed on medicines by the FDA, thedistribution of some medicines are also restricted or regulated by oneor more federal and or state governmental agencies such as theDepartment of Justice (DOJ), the Drug Enforcement Agency (DEA) orindividual State Boards of Pharmacy.

For example, pseudoephedrine (PSE) is a medicine that hasnon-prescription status, and is commonly used as a decongestant.However, PSE can also be used in the production of illicit and illegaldrugs such as, but not limited to, methamphetamine. As such,governmental agencies have required that merchants or regulated sellersof PSE and PSE containing products regulate or restrict the distributionof PSE and PSE containing products. The restriction of PSE and PSEcontaining products typically includes moving the location of suchproducts to a behind-the-counter setting in order to track the sales ofsuch products. The compliance for documenting sales information andpurchaser information is typically performed at the point-of-sale.Accordingly, although PSE is a non-prescription medicine, which wouldotherwise be made available in an over-the-counter setting, other agencyregulations and distribution restrictions related to its sale havecaused retailers to move this medicine to a behind-the-counter settingto capture the compliance information, Thus, state authorities have theability to schedule any over-the-counter medicine and to move thesemedicines to a behind-the-counter setting for reasons of public health.

More recently, certain medicines have been classified as dual statusmedicines in the United States. Dual status medicines are medicines thathave a non-prescription classification for certain portions of thepopulation, but maintain a prescription classification for otherportions of the population. For example, the emergency oralcontraceptive Plan-B can be dispensed without a prescription to womenover the age of 18, but is dispensed to women under the age of 18 onlywith a prescription. Accordingly, other medicines, such as theaforementioned oral contraceptive, have both a prescription andnon-prescription classification. These dual status medicines areavailable only behind-the-counter of the pharmacy as certain criteria,such as age verification by the licensed practitioner, must be metbefore dispensing without a prescription.

Most countries regulate the distribution of medicines in a mannersimilar to the regulations for dispensing medicines in the United Statesdiscussed above.

For example, Australia utilizes a medicine distribution system thatclassifies the available distribution system into four differentcategories or schedules, namely Unscheduled, Schedule 4, Schedule 3, orSchedule 2. It should be noted that the term schedule as used in theAustralian classifications system is not the same as that used under theU.S. system and referenced under U.S.C. 812 and the Controlled SubstanceAct.

In Australia, unscheduled medicines are general sale products that areavailable without prescription or interaction with a pharmacist and,thus, are typically available over-the-counter at any retail location.In contrast, medicines classified as Schedule 4 and Schedule 3 arelocated behind-the-counter, while Schedule 2 are located in front of thepharmacy counter. More particularly, medicines classified as “Schedule 4medicines” are available by prescription only and are available fordistribution from behind-the-counter by a pharmacist in a pharmacylocation. Medicines classified as “Schedule 3 medicines” are availablewithout a prescription (i.e., a non-prescription medicine), but can besupplied only by a pharmacist in a pharmacy location. Thus, Schedule 3medicines are available for distribution from behind-the-counter toallow for the necessary pharmacist-patient interaction. Medicinesclassified as “Schedule 2 medicines” are available without aprescription, but may require advice from a pharmacist prior todispensing. As such, Schedule 2 medicines are also available fordistribution and access from in front-the-counter, and to provide theopportunity for a pharmacist-patient interaction at a pharmacy locationonly.

As another example, the United Kingdom utilizes a medicine distributionsystem that classifies the medicine into one of three categories, namelygeneral sales, pharmacy sales, and prescription sales. As the namesuggest, general sales medicines are available without prescription orneed for any interaction with a pharmacist and, thus, are availableover-the-counter in the general sales area of a retail outlet. Pharmacysales are available without prescription, but provide a means for aninteraction with a pharmacist and, thus, are availablebehind-the-counter of the pharmacy. Further, prescription sales areavailable only with a prescription and, thus, are only availablebehind-the-counter of the pharmacy.

As seen from the discussion above, the distribution of medicines istypically based on a classification system, which generally results inthe medicine either being available without distribution restrictionsover-the-counter, which does not require interaction with doctor orpharmacist, or being available with distribution restrictions behind-thecounter, which requires interaction with a pharmacist, or otheremployee.

It has been determined by the present disclosure that the distinctionbetween medicines available with restrictions “behind-the-counter” andthose available with or without restriction “over-the-counter” isimportant to the retail outlet or merchant selling the medicine. Morespecifically, “over-the-counter” medicines without restrictions do notrequire licensed pharmacy sites or any interactions with an employee orpharmacist when being purchased by a purchaser. In contrast,“behind-the-counter” medicines and age restricted over the countermedicines do require interaction with an employee when being purchasedby a purchaser.

In addition to regulations placed on medicines discussed in detailabove, the distribution of many medical devices such as, but not limitedto, hypodermic needles, HIV tests, certain orthopedic devices are alsoregulated. For example, many states require the sale of hypodermicneedles to be made from behind-the-counter and/or only to persons over apredetermined age. In addition, some medical devices are only availablewith a prescription. Thus, access to many non-medicinal medical devicesare faced with similar distribution difficulties discussed hereinabove.

Further, many products fall into a more general class of productsreferred to herein as “nutraceuticals”, which includes products such as,but not limited to, nutritional supplements, functional foods, dietarysupplements, vitamins, botanicals, medical foods, and others. It iscontemplated that one or more of the aforementioned and othernutraceuticals may have a restricted distribution status imposed thereonby a regulating body, by the manufacturer, by the retail outlet, and anycombinations thereof.

In addition, the distinction between medical products available“behind-the-counter” and those available “over-the-counter” is importantto the consumers who have a desire to use or select certain medicalproducts. For instance, the over-the-counter medical products that donot require interaction with an employee and makes the medical productsmore easily obtainable by the consumer.

Accordingly, it has been determined by the present disclosure that thereis a continuing need for systems and methods for dispensing medicalproducts having a non-prescription status without the need for theadditional access restraints and restrictions traditionally associatedwith such behind-the-counter and pharmacy sales only. Further, it hasbeen determined by the present disclosure that there is a need formethods of switching prescription medical products to non-prescriptionstatus using an electronic vending machine as a means to aid, assist andrestrict access to ensure the safe and effective use of suchprescription products in an over-the-counter environment.

Further, it has been determined by the present disclosure that there isa continuing need for systems and methods for dispensing medicineshaving a non-prescription status without the need for the additionalaccess restraints and restrictions by retailers who use physicalbarriers or place medical products and devices behind the counter orunder the control of a sales employee in order to restrict access due toconcerns of theft.

BRIEF SUMMARY OF THE DISCLOSURE

The present disclosure provides methods for dispensing non-prescription,behind-the counter medical products (i.e., medicines, nutraceuticals,and medical devices) using a vending machine in conjunction with anelectronic self-selection process.

The present disclosure also provides methods for dispensingnon-prescription, behind-the counter medical products from a vendingmachine in a general sales location using a vending machine inconjunction with both selecting and de-selecting processes.

In some embodiments, the present disclosure provides methods ofdispensing non-prescription, behind-the counter medical products from avending machine in a general sales location using a self-selecting stepthat is based, at least in part, on biometric data. The biometric datacan be locally inputted by purchaser (manually or by attaching abiometric measuring device) or retrieved by the vending machine from areference lab or other external source.

In still other embodiments, the present disclosure provides systems andmethods for switching prescription medical products to non-prescription,over-the-counter status. Here, the systems and methods of the presentdisclosure provide for interactive compliance to the collateral measuresnecessary to meet the requirements set forth by the FDA for switchingsuch prescription medicines.

A method for dispensing restricted distribution medical products isprovided. The method includes identifying a particular medical producthaving a distribution restricted status; placing a vending machine in ageneral sales location, the vending machine having a user-interface incommunication with a controller; storing a supply of the particularmedical product in the vending machine; storing an electronicself-selection process on the controller; and controlling the vendingmachine, via the controller, to dispense a first sales unit of theparticular medical product only if a purchaser successfully completesthe self-selection process for an initial purchase request for theparticular medical product via the user interface.

A method of dispensing non-prescription, behind-the-counter medicalproducts from a vending machine in a general sales location is alsoprovided. The method includes accepting a purchase request at a vendingmachine from a purchaser for a particular non-prescription,behind-the-counter medical product; determining if the purchase requestis an initial purchase request or a subsequent purchase request by thepurchaser for the particular medical product; accessing a self-selectionalgorithm for the particular medical product if the purchase request isthe initial purchase request; accessing a de-selection algorithm for theparticular medical product if the purchase request is the subsequentpurchase request; requiring the purchaser to input an answer to each ofa plurality of questions generated by the self-selection algorithm orthe de-selection algorithm; and controlling the vending machine, via theself-selection algorithm or the de-selection algorithm, to dispense ornot dispense the particular medical product based the answers.

In some embodiments, a method of dispensing a medical product from avending machine in a general sales location is provided. The methodincludes accepting a purchase request at a vending machine from apurchaser for a particular medical product; accessing a dispensingalgorithm for the particular medical product; requiring the purchaser toinput an answer to each of a plurality of questions generated by thedispensing algorithm; collecting biometric data from the purchaser; anddetermining whether or not to dispense the particular medical productbased on the answers and based, at least in part, on the biometric data.

A medical product dispensing system is also provided that includes avending machine, one or more user-interface devices, and a controller incommunication with the vending machine and the one or moreuser-interface devices. The vending machine defines a storage space thatcan receive one or more restricted distribution medical products and oneor more unrestricted distribution medical products therein. The systemfurther includes a self-selection algorithm resident on the controllerfor each of the restricted distribution medical products in the storagespace. The controller, upon selection of a particular restricteddistribution medical product by a purchaser via the one or moreuser-interface devices, is configured to determine whether the selectionof the particular restricted distribution medical product is a firstrequest or a second or subsequent request for the particular restricteddistribution medical product. The controller requires the purchaser tocomplete the self-selection algorithm if the request is the firstrequest. The controller dispenses the particular restricted distributionmedical product only if the purchaser successfully completes theself-selection algorithm.

A method for distributing a medical product is provided that includes:providing a controller having a matching algorithm resident thereon;allowing a purchaser to access to the matching algorithm; controllingthe matching algorithm to provide a plurality of exemplary symptoms ordisease-states to the purchaser via at least one data entry andcommunication device in visual or auditory form; allowing the user toselect one or more symptoms or disease-states from the plurality ofexemplary symptoms or disease-states when the one or more symptoms ordisease-states match those currently being experienced by the purchaser;and controlling the matching algorithm to provide a list of one or moreappropriate medical products for the one or more symptoms ordisease-states selected.

A method for distributing a medical product is provided that includes:storing an electronic self-selection process related to the medicalproduct on a controller; storing an electronic de-selection processrelated to the medical product on the controller; allowing a potentialpurchaser of the medical product to access the electronic self-selectionand de-selection processes; controlling the controller via theelectronic self-selection process to provide an transaction record forthe medical product only if the potential purchaser successfullycompletes the self-selection process for an initial purchase request ofthe medical product; and controlling the controller via the electronicde-selection process to provide the transaction record for the medicalproduct only if the potential purchaser successfully completes thede-selection process for a second or subsequent purchase request of themedical product.

The above-described and other features and advantages of the presentdisclosure will be appreciated and understood by those skilled in theart from the following detailed description, drawings, and appendedclaims.

BRIEF DESCRIPTION OF THE OF THE DRAWINGS

FIG. 1 is a schematic view illustrating an exemplary embodiment of amedical product dispensing system according to the present disclosure;

FIG. 2 illustrates the various classes of medical products that arecontemplated for use with the dispensing system of FIG. 1;

FIG. 3 illustrates a method for dispensing medical products according toan exemplary embodiment of the present disclosure;

FIG. 4 illustrates an alternate exemplary embodiment of a method fordispensing medical products according to the present disclosure;

FIG. 5 illustrates another alternate exemplary embodiment of a methodfor dispensing medical products according to the present disclosure;

FIG. 6 illustrates an exemplary embodiment of a method for switching abehind-the-counter, prescription medical products to anover-the-counter, non-prescription medical product using a vendingmachine according to the present disclosure;

FIG. 7 illustrates an alternate exemplary embodiment of the method ofFIG. 6;

FIG. 8(a) through FIG. 8(g) illustrate an exemplary embodiment of aself-selection algorithm and a de-selection algorithm; and

FIGS. 9 through 11 are schematic views illustrating alternate exemplaryembodiments of a medical product dispensing system according to thepresent disclosure.

DETAILED DESCRIPTION OF THE DISCLOSURE

Referring to the drawings and in particular to FIG. 1, an exemplaryembodiment of a medical product dispensing system 10 is shown.Advantageously, system 10 is configured to dispense medical productshaving restricted distribution requirements without the need forinteraction between the purchaser/user/consumer (hereinafter purchaser)and a licensed practitioner or other sales associate.

It should be understood that the purchaser of the medical product may bethe same as or different from the user of the medical product. Forexample, it is contemplated by the present disclosure for a parent orother guardian to purchase the medical product for a child or otherdependant. However, and for purposes of clarity, the present disclosureshall be described by way of example only having the purchaser and userbeing one and the same. Thus, the user of system 10, the user of themedical product, and the purchaser are, for purposes of clarity,described herein being one and the same.

System 10 provides an effective guide to the purchaser through a seriesof medical history and medical product related questions, and alsoprovides product specific information of interest and importance to thepurchaser.

Thus, system 10 provides an electronic device to replace a learnedintermediary (i.e., licensed practitioner) by capturing the criticalelements that a learned intermediary provides, and also provideseffective collateral methods for the safe and effective use of aprescription or restricted access medical product in an over the counterenvironment.

More particularly, system 10 provides an interactive computer controlledvending machine having access to a purchaser recognition system, aproduct specific self-selection algorithm 24 and, in some embodiments, aproduct specific de-selection algorithm 26 for any medical product. Thesystem 10 dispenses the medical product selected by a purchaser if thepurchaser qualifies for the medical product. In the instance where themedical product has restrictions for distribution based on the product'slabeling or governmental agency specifications, system 10, as determinedby the self-selection algorithm 24 in accordance with informationinputted by the purchaser, determines whether the purchaser qualifiesfor the medical product. Upon subsequent requests for the particularmedical product, the system 10 can dispense a subsequent sales unit ofthe particular medical product if the purchaser remains qualified forthe medical product as determined by the de-selection algorithm 26 inaccordance with the prior and new information inputted by the purchaser,or limitations as specified by the label or other governmental agencies.

In an exemplary embodiment of the present disclosure, system 10 includesa vending machine 12 having one or more person-machine-interface devices14. System 10 also includes a controller 16 in communication withvending machine 12 and interface devices 14. Vending machine 12 definesa storage space 18 configured to receive one or more different medicalproducts 20 therein.

FIG. 2 illustrates the various categories of medical products 20 thatare contemplated for use with the dispensing system of FIG. 1. Forexample, system 10 can be used to distribute certain over-the-counter,non-prescription medical products 20 a that can be sold without anydistribution restrictions imposed by a regulating body (e.g., FDA, DEA).Here, system 10 may distribute medical products 20 a without the needfor algorithms 24, 26. For example, medical products 20 a can includethose products that have restricted access due to theft or shrinkage.Further, it is contemplated by the present disclosure for a retailcompany and/or product manufacturer to place restrictions on the use ofone or more medical products 20 a that differ (e.g., may be morestringent) from those required by the aforementioned regulating bodies.In these instances, the retailer and/or manufacturer may opt to usealgorithms 24, 26 in the distribution of various medical products 20 a.

In addition, system 10 can be used to distribute other medical products20 b, 20 c, and 20 d that have one or more distribution restrictions.

Thus, system 10 can be used to distribute certain over-the-counter,non-prescription medical products 20 b (e.g., PSE containing productsand the like) that can be only be sold upon verification of one or moreattributes, such as age of the purchaser. It is also contemplated by thepresent disclosure for system 10 to be updated to include otherover-the-counter, non-prescription medical products 20 b that may belater changed to restricted sales.

System 10 distributes medical products 20 b without the need forde-selection algorithm 26, but rather uses a selection algorithm 24 thatrequires only birth date or age verification and, in some instances, anumber of purchases of the particular medical product 20 b within apredetermine period of time. In this embodiment, system 10 can beconfigured to store or save purchase data on controller 16. Sincecontroller 16 is, in some embodiments, common to multiple retaillocations, system 10 is configured to automatically monitorstore-to-store purchases of restricted medical products 20 b (e.g., PSEcontaining products). In this manner, system 10 can prevent the sale ofsuch restricted medical products based on allowed purchase quantitieseven though the purchaser's information (i.e., age) meets the necessarylimits.

System 10 can be used to facilitate, or provide the collateral methodsto allow for the distribution of certain behind-the-counter,non-prescription medical products 20 c, such as the aforementioned dualstatus medicines, medicines classified as Schedule 4 and Schedule 3 inAustralia, and pharmacy sales in the United Kingdom.

Also, system 10 can be used to facilitate, or provide the collateralmethods to allow for the distribution of certain behind-the-counter,prescription medical products 20 d that meet or can be made to meet therequirements for being “switched” from prescription to non-prescriptionstatus. Further, system 10 can be used to facilitate, or provide thecollateral methods to allow for the distribution of certainbehind-the-counter, non-prescription medical products 20 c that meet orcan be made to meet the requirements for being “switched” frombehind-the-counter to an over-the-counter status.

During the distribution of medical products 20 c, 20 d, system 10provides, via algorithms 24, 26, an interactive collateral measurescompliance device that, for example, ensures compliance to the labelingrequirements and thus, ensures the confidence necessary for switchingthe medical products from prescription to non-prescription status and/orfrom behind-the-counter status to over-the-counter status.

Accordingly, as used herein the term “distribution restricted medicalproducts” includes one or more of products 20 b, 20 c, and 20 d.

Referring again to FIG. 1, interface device 14 can be any type of dataentry and communication device 14-1 such as, but not limited, to visualdisplay screen, a standard alphanumeric key board, a mouse or pointingdevice, a touch screen, a credit card reader, a bar code reader, aspeaker, a microphone, a voice recognition device, a printer, a wiredcommunication port, a wireless communication port, and any combinationsthereof. In this manner, a purchaser using vending machine 12 can inputpersonal information, if required, such as name, address, medicalinsurance information, age and past medical history, current over thecounter or prescription medication information, payment information, andother information requested by controller 16 and used by algorithms 24,26 to determine whether to dispense medical product 20 to the purchaser.

When vending machine 12 is not in use, system 10 controls data entry andcommunication device 14-1 via controller 16 to provide verbal and/orvisual health information and/or advertising to people in the vicinityof the vending machine. Data entry and communication device 14-1 can bephysically incorporated into vending machine 12 or can be in electricalcommunication with the vending machine

In other embodiments, and as will be discussed in more detail hereinbelow, interface device 14 can also include one or more identificationdevices 14-2, one or more biometric data devices 14-3, one or morepayment devices 14-4 (only one shown), and any combinations thereof.

In its simplest form, the identity of the purchaser can be accomplishedby the purchaser manually entering in their identity information viadata entry and communication device 14-1. In other embodiments orsupplemental to this embodiment, system 10 can include identificationdevice 14-2 that is any device commonly used to electronically verifythe identity of particular purchaser. For example, identification device14-2 can be a magnetic stripe reader or bar code reader that acceptsinformation from an identification card such as a driver's license,medical insurance or medical history and medical diagnostic card shouldsuch technology be developed, credit card, and others. In otherembodiments, identification device 14-2 can include more complex aidentification device such as, but is not limited to, a finger printscanner, a retinal scanners, a facial recognition device, a DNA scanner,and any combinations thereof.

Biometric data collection device 14-3 is integral to vending machine 12and is configured to measure one or more biometric characteristics ofthe purchaser for use by system 10 in the self-selection algorithm 24and, when necessary, the de-selection algorithm 26. For example,biometric data collection device 14-3 can be a device such as, but notlimited to, a blood pressure monitor or a blood glucose monitor suchthat system 10 can collect a blood pressure reading or glucose readingfrom the device.

As used herein, the terms “biometric data” and “biometriccharacteristics” are used interchangeably and shall collectively meanmeasured data representative of one or more physiological conditions ofthe purchaser. Such “biometric data” and “biometric characteristics” canbe measured via contact directly with the purchaser via for example, ablood pressure cuff, a thermometer, an infrared blood gas analyzer, andthe like. The “biometric data” and “biometric characteristics” can alsobe measured via samples taken from the purchaser such as height, weight,whole blood, serum, saliva, urine, feces and any combinations thereof.Furthermore, the “biometric data” and “biometric characteristics” caninclude any clinically measurable values normally obtained by a licensedmedical practitioner via a physical exam or ordered as part of formallaboratory analysis.

It should be recognized that the present disclosure illustratesbiometric data collection device 14-3 by way of example only ascollecting blood pressure and blood glucose data. Of course, it iscontemplated by the present disclosure for biometric data collectiondevice 14-3 to collect any purchaser biometric data such as, but notlimited to, purchaser body temperature, blood sugar, the level of thelow density lipoprotein (LDL) form of cholesterol, the level of the highdensity lipoprotein (HDL) form of cholesterol, the total cholesterollevel, triglyceride level, blood oxygen saturation rates, heart rate,blood pressure, body temperature, lung function indices (i.e., forcedexpiratory volume) or any other pulmonary, cardiovascular, blood, urineand stool chemistry analysis information available to a licensedhealthcare practitioner.

It should also be recognized that vending machine 12 is not limited toentry of biometric data only via biometric data collection device 14-3.Rather, it is contemplated by the present disclosure for vending machine12 to allow collection of biometric data in a plurality of ways of whichcollection device 14-3 allows for measurement directly at the vendingmachine.

In some embodiments, the purchaser can input biometric data via dataentry and communication device 14-1. For example, the purchaser couldtype in a blood pressure or cholesterol reading into vending machine 12via data entry device 14-1. Alternately, the purchaser could present adiagnosis card 30 or medical history card to the data entry device 14-1for the data entry device to scan or read the information on the card,including biometric data, if any, into the vending machine.

Alternately, the purchaser could place a purchaser supplied biometricmeasurement device (not shown) in electrical communication with vendingmachine 12 via data entry and communication device 14-1 in exampleswhere the data entry device is a communication port. In this manner, apurchaser could connect a purchaser provided device, such as a bloodglucose monitoring device, to vending machine 12 and download orcommunicate one or more data points to system 10.

In still other embodiments, the purchaser can input biometric data viadata entry and communication device 14-1 by using the data entry deviceto authorize controller 16 to obtain the biometric data from an externaltest or laboratory site 28. For example, prior to interfacing withvending machine 12, the purchaser could submit themselves to one or moretesting protocols at external test site 28. The results of these testingprotocols being stored on a database 30 associated with the externaltest or laboratory site 28. Here, the purchaser can authorize vendingmachine 12 to access the results available on database 30 via a networkconnection such as the Internet.

Payment device 14-4, if desired, can accept one or more types ofpayment. For example, payment device 14-4 can be a credit card reader ora debit card reader, can be a cash or coin accepting device, and anycombinations thereof. In some embodiments, vending machine 12 candetermine via controller 16 the purchaser's cost for medical product 20based on insurance provider information entered by the purchaser.

Vending machine 12 and/or controller 16 can be configured to controlstorage space 18 to store medical product 20 at an ambient storagecondition, a conditioned storage condition, or any combinations thereof.As used herein, the ambient storage condition shall mean that medicalproduct 20 is exposed to an amount of light, a storage temperature, anda storage humidity within space 18 that is ambient to the location wheremachine 12 resides. In contrast, the conditioned storage condition shallmean that space 18 is controlled to meet a recommended storage conditionfor medical product 20 by controlling or conditioning one or more of anamount of light, a storage temperature, a storage humidity, and anycombinations thereof.

It is further contemplated for vending machine 12 to include a pluralityof storage spaces 18, where some spaces are controlled to ambientstorage conditions acceptable for medical product 20 therein, whileother spaces provide controlled storage conditions acceptable formedical product 20 therein.

In this manner, vending machine 12 can be configured, as needed, tostore any desired medical product 20 within space or spaces 18.

It should be recognized that vending machine 12 is described above byway of example as defining one or more storage spaces 18 therein.However, it is contemplated by the present disclosure for storage spaces18 to be an auxiliary storage device 18-1 that is physically attached toor otherwise controlled by vending machine 12 and/or controller 16. Forexample, it is contemplated by the present disclosure for storage spaces18 to be defined in a drawer-like drug supply cabinet such as thosecommercially available in the hospital setting.

Medical product 20 can be stored or packaged in a selected sales unitappropriate for the particular medicine and condition being treated. Insome instances, the selected sales unit size may be subject to FDA orother governmental agency requirement. For example, medical product 20can be stored in a sales unit having a thirty-day supply of the medicalproduct.

In one embodiment, vending machine 12 includes one or more sensors (notshown) in communication with controller 16. In this manner, system 10can monitor the internal inventory of medical product 20 within spaces18 and communicate to a vendor or retailer when refill is needed.

In the illustrated embodiment of system 10, controller 16 is shown beingremote from vending machine 12 and communicating with one another via anetwork 22. However, it is also contemplated by the present disclosurefor controller 16 to be resident in vending machine 12. Moreover, it iscontemplated for system 10 to include two controllers, one resident invending machine 12 and one remote from the vending machine, where thetwo controllers communicate over network 22. Network 22 can be anydesired communication network such as, but not limited to, awide-area-network, the Internet, and others.

System 10 includes self-selection algorithm 24 and, in some embodiments,de-selection algorithm 26 resident on controller 16. In one embodiment,controller 16 and, hence algorithms 24, 26, reside in a central locationin electrical communication with a plurality of vending machines 12. Inother embodiments, controller 16 and, hence algorithms 24, 26, areresident on one vending machine 12. Here, algorithms 24, 26 areautomatically updated from a remote central location, as desired.

In use of system 10, a purchaser requests the purchase of a particularmedical product 20 stored within vending machine 12 via input device 14.In response to the purchase request, controller 16 can control vendingmachine 12 to request the purchaser to enter particular general personalinformation specific to the purchaser such as, but not limited to, name,age, address, social security number, past medical history, currentmedications, past use of the particular medical product, and the like.Of course, it is contemplated by the present disclosure for vendingmachine to not require any personal information be entered by thepurchaser.

Based on the particular medical product 20 being requested and, whenrequired, the general personal information, controller 16 determineswhether the purchase request is a first or initial request for theparticular medical product 20 by the purchaser. In other embodimentswhere no personal information is available, controller 16 can ask thepurchaser whether the purchase request is a first or initial request ora second or subsequent request for the particular medical product 20 bythe purchaser. If the request is an initial request, controller 16executes self-selection algorithm 24. However, if the request is not aninitial request, but rather is a second or subsequent request, thecontroller 16 executes de-selection algorithm 24.

Broadly speaking, self-selection algorithm 24 determines if thepurchaser is eligible for use of medical product 20, while de-selectionalgorithm 26 determines if the purchaser remains eligible for themedical product.

As used herein, the term “self-selection” is the process of a purchaserusing a product specific algorithm that reflects those critical concernsand information identified by the governmental agency and included inthe product's label, and then help or guide the purchaser on whether ornot to select or use a particular product based on information listed onthe product label taking into account his/her personal medical history,demographics and signs and symptoms of the condition to be treated. Theself-selection process provides a risk-benefit analysis at the time ofinitial purchase so that the benefit of starting treatment is weighedagainst the risks associated with not starting treatment or seeking aphysician's advice.

As used, herein the term “de-selection” is the process where thepurchaser, who has already started therapy with a particular product,has again reviewed the critical elements and information (e.g.,warnings, cautions, directions) of the approved label as well as theircurrent medical history to make a determination of whether use of theproduct should be continued or discontinued. The de-selection processmay also contain the same or different questions of critical interestthat were listed in the self-selection process. The de-selection processprovides a risk-benefit analysis each time the purchaser attempts tore-purchase a particular product so that the benefit of continuingtreatment is weighed against the risks associated with continuingtreatment. Further, de-selection process can automatically limit thelength of therapy to a predetermined length by for example monitoringhow many purchase requests for the particular medical product have beenmade by the particular user.

Selection algorithm 24 is configured to pose a plurality of questions tothe purchaser via data entry and communication device 14-1 based on theapproved labeling of the purchaser's desired medical product 20. In someinstances, the plurality of questions can include purchaseracknowledgement of specific warnings or other critical information. Thepurchaser's answers to the questions are entered via devices 14-1, 14-2,and 14-3, as required. In response, to the purchaser's answers,selection algorithm 24 determines whether the purchaser is eligible forthe particular medical product 20 requested.

De-selection algorithm 26 is also configured to pose a plurality ofquestions to the purchaser via data entry and communication device 14-1based on the purchaser's desired medical product 20 and past use of thesystem 10. Again, in some instances, the plurality of questions caninclude purchaser acknowledgement of specific warnings or other criticalinformation. The purchaser's answers to the questions are entered viadevices 14-1, 14-2, and 14-3, as required. In response, to thepurchaser's answers, selection algorithm 24 determines whether thepurchaser is eligible for continued use of the particular medicalproduct 20 requested.

Thus, system 10 restricts access to medical product 20 when thepurchaser's information and past use of the system 10 for the samemedication or device, as determined by algorithms 24, 26, does notcomply with the necessary conditions, labeling or restrictions for theselected medical product. For example, incorrect answers to questionsprovided by algorithms 24, 26 results in controller 16 preventingvending machine 12 from dispensing medical product 20.

System 10 provides a patient driven system, located at thepoint-of-sale, that establishes the patient identification, acceptsfirst and subsequent purchase requests for a particular medical product20, uses algorithms 24, 26 to determine if that patient is eligible toreceive or continue to receive that medical product, provides warningand heeding information to the purchaser about the medication via dataentry and communication device 14-1 in verbal, display and/or printedform, reviews and calculates and limitation or compliance requirementsas indicated in the approved labeling or set by governmental agencies,and completes the sales transaction via payment device 14-4, if desired,and dispenses the medical product when appropriate.

Advantageously, system 10 provides accuracy and compliance to theselection criteria within algorithms 24, 26, and approved labeling,provides significant consumer education before and during use, providesfull retail access to medical products 20 having restricted distributionstatus (i.e., products 20 b, 20 c, and 20 d), handles the salestransaction at the vending machine 12, verifies that the medicalcondition still exists when subsequent purchases are requested,documents and saves patient information, accesses information andprovide a reason for denial or need to be referred to a Doctor,documents and saves sales information (e.g., PSE) without the need for apharmacist or other retail employee. Thus, system 10 can be used forFDA/DEA/State mandated restricted medical products (e.g., PSE containingproducts, dual status medicines, and the like), as well as for worldwidebehind-the-counter drug restrictions models.

In this manner, system 10 can be used to transfer a non-prescription,behind-the counter medical product to a general sales medical productwithout the need of the intervention of licensed health carepractitioners. System 10 can be used as an approved risk management tooland a collateral method to allow for the switch of a prescriptionmedical product to a non-prescription, over-the-counter or general salesmedical product. Further, system 10 can be used as an approved riskmanagement tool and a collateral method to allow for the switch of anon-prescription, behind-the-counter medical product to anover-the-counter or general sales medical product.

In the event that system 10 determines, via self-selection orde-selection algorithms 24, 26, that the purchaser is not qualified toreceive the particular medical product 20 selected, the system controlsvending machine 12 to not dispense the medical product 20. In someembodiments, system 10 can provide instructions, directions, and/oradvice to the purchaser, via data entry and communication device 14-1,regarding the steps necessary to obtain the particular medical product.For example, system 10 can provide a written instruction, a visualinstruction, a verbal instruction, and any combinations thereof (viadata entry and communication device 14-1).

Referring now to FIG. 3, a method for transferring non-prescription,behind-the-counter or over-the-counter medical product havingdistribution restrictions to a general sales medical product isillustrated generally by reference numeral 40.

Method 40 identifies a particular behind-the-counter or over-the-countermedical product that has one or more distribution restrictions (20 b, 20c) to be transferred at step 42 and places a vending machine 12 in ageneral sales location at step 44. As discussed above with respect toFIG. 1, vending machine 12 has interface device 14 in communication witha controller 16.

Method 40 includes storing a supply of the medical product in thevending machine at step 46 and storing an electronic selection process24 on the controller 16 at step 48. Next, method 40 controls the vendingmachine, via the controller, to dispense a first sales unit of theparticular medical product only if a purchaser is identified andsuccessfully completes the self-selection process based on either theapproved labeling requirements or other governmental restrictionregarding an initial purchase request for the medical product via theinterface device 14 at step 50.

In some embodiments, method 40 further includes storing an electronicde-selection process 26 on the controller 16 at step 52. Finally, method40 controls the vending machine, via the controller, to dispense asecond or subsequent sales unit of the particular medical product onlyif a purchaser successfully completes the de-selection process and meetsthe approved labeling requirements or other governmental restrictionregarding for a second or subsequent purchase request for the particularmedical product via the interface device 14 at step 54.

In other embodiments, method 40 can include a warning step 56 before orafter dispensing step 50 or 54. Here, method 40 can provide a warning,caution, and/or instruction (herein after “information”) to thepurchaser via data entry and communication device 14-1 regarding the useof the particular medical product. For example, method 40 can controldata entry and communication device 14-1 at step 56 to provide writteninformation, visual information, verbal information, and anycombinations thereof.

It is contemplated by the present disclosure for method 40, at step 56,to customize the information to the particular purchaser using thebiometric data and/or one or more of the purchaser's answers.

Referring now to FIG. 4, an alternate exemplary embodiment of a methodfor transferring non-prescription, behind-the counter medical productsto general sales medical products is illustrated generally by referencenumeral 60.

Method 60 includes a step 62 where a purchase request from a purchaserof the vending machine 12 for a particular non-prescription,behind-the-counter medical product 20 is accepted. Once accepted, method60 includes a determining step 64, where the method determines if thepurchase request is an initial purchase request or a subsequent purchaserequest by the purchaser for the particular medical product. Method 60then accesses a selection algorithm if the purchase request is theinitial purchase request at step 66 or a de-selection algorithm if thepurchase request is the subsequent purchase request at step 68.

After accessing the appropriate algorithm, method 60 requires thepurchaser to input an answer to each of a plurality of questions andreviews information generated by the selection algorithm or thede-selection algorithm at step 70. Next, method 60 controls the vendingmachine, via the selection algorithm or the de-selection algorithm, todispense or not dispense the particular medical product based theanswers at step 72.

In other embodiments, method 60 can include a warning and caution step74 before or after steps 70 or 72. Here, method 60 can provide awarning, caution, and/or instruction (herein after “information”) to thepurchaser via data entry and communication device 14-1 regarding the useof the particular medical product. For example, method 60 can controldata entry and communication device 14-1 at step 74 to provide writteninformation, visual information, verbal information, and anycombinations thereof.

It is also contemplated by the present disclosure for method 60, at step74, to customize the information to the particular purchaser using thebiometric data and/or one or more of the purchaser's answers.

It is also contemplated by the present disclosure for warning step 74 toinclude the potential follow-up with the purchaser by a licensedpractitioner or other practitioner regarding the purchase of the medicalproduct if so indicated by the label.

For example, system 10 can provide contact data from the purchaser to amanufacturer of the medical product or to the owner of the system 10. Inthis manner, the purchaser can be contacted in a follow-up manner,namely a predetermined period of time after the purchase, to provide anycritical information regarding the safe and effective use of theproduct, and determine whether the purchaser has any questions or shouldhave any follow-up regarding the use of the medical product.Advantageously, system 10 can provide the data necessary for thefollow-up in a manner that complies with the requirements of the HealthInsurance Portability and Accountability Act (HIPAA).

In another example, system 10 can communicate a follow-up reminderdirectly to the purchaser. In some embodiments, system 10 can send ane-mail message, an electronic phone message, a text message, a mailedletter directly to the purchaser reminding the purchaser to, forexample, verify their blood pressure is below a predetermined limit orto see there physician if the signs and symptoms of the condition beingtreated become worse.

Referring now to FIG. 5, an exemplary embodiment of a method ofdispensing medical products is illustrated generally by referencenumeral 80.

Method 80 includes a step 82 where a purchase request from a purchaserof the vending machine 12 for a particular medical product 20 isaccepted. Once accepted, method 80 then accesses a dispensing algorithmfor the particular medical product at step 84.

After accessing the appropriate algorithm, method 80 requires thepurchaser to input an answer to each of a plurality of questions and seeinformation generated by the algorithm at step 86. Next, method 80requires a purchaser to input biometric data at step 88. Next, method 80determines whether to dispense or not dispense the particular medicalproduct based on the answers and at least in part on the biometric dataat step 90.

It is also contemplated by the present disclosure for method 80, at step90, to use the biometric data and/or the purchaser's answers tocustomize the purchase of the medical product for the purchaser. Forexample, method 80, at step 90, can use the biometric data (e.g.,weight) and/or one or more of the purchaser's answers (e.g., age) tocustomize one or more attributes of the purchase. The attributes of thepurchase that can be customized by method 80 based on the answers and atleast in part on the biometric data at step 90 can include a dosage ofthe medical product, a use instruction for the user, a warning, andothers.

Thus, method 80 can not only determine whether or not to dispense theparticular medical product based on the answers and at least in part onthe biometric data at step 90, but also to customize one or moreattributes of the purchase.

In some embodiments, the biometric data of step 88 can be inputtedlocally at the vending machine 12 at step 92. For example, the locallyinputted data at step 92 can be inputted to system 10 via communicationdevice 14-1 or by connecting a purchaser supplied biometric measurementdevice (not shown) to vending machine 12 via data entry andcommunication device 14-1 as discussed above with respect to FIG. 1.Also, the locally inputted data at step 92 by measuring at step 94 thebiometric data directly at vending machine 12 via biometric datacollection device 14-3 as discussed above with respect to FIG. 1.

In other embodiments, the purchaser can authorize at step 96 vendingmachine 12 to obtain the biometric data from an external test site 28 asdiscussed above with respect to FIG. 1.

The systems and methods according to the present disclosure, byeliminating the need to interact with a pharmacist or learned healthcare intermediate, allows the dispensing of non-prescription,behind-the-counter medical products in locations previously impossible.

Moreover, it has been determined by the present disclosure that thesystems and methods according to the present disclosure advantageouslyallow medical products having a prescription status, to be switched, insome instances, to over-the-counter, non-prescription status and/or formedical products having a behind-the-counter status, to be switched toan over-the-counter status.

Medical products that the FDA has already approved for prescription usecan be “switched” to non-prescription use when it has been determined tothe satisfaction of the FDA that, among other factors, the medicalproduct is safe for use under the conditions suggested in the proposedlabeling. Such “switch” applications generally require data from actualuse and labeling comprehension studies to demonstrate that the productcan be safely and effectively used without the supervision of apractitioner licensed by law to administer or use the product. System 10advantageously provides an interactive collateral measures andcompliance device that, for example, ensures compliance to the labelingrequirements and thus, enhances the confidence associated with switchingmedical product from prescription to non-prescription status.

Advantageously, the systems and methods of the present disclosureprovide risk management and collateral method models that easily andeffectively address the issues with label comprehension, labelcompliance, and chronic use.

An exemplary embodiment of a method of switching a prescription medicalproduct to a non-prescription, over-the-counter medical productaccording to the present disclosure is illustrated in FIG. 6 andgenerally referred to by reference numeral 100.

Method 100 includes a medicine selection step 102, where a particularmedical product having a prescription status is selected to be switchedto a non-prescription, over-the-counter status.

Once selected, method 100 includes a first developing step 104, where aset of initial dispensing criteria a developed. The set of initialdispensing criteria for the particular medical product includes criteriasufficient to a responsible regulatory agency, such as the FDA, toauthorizing changing the status of the medical product to thenon-prescription status. Next, method 100 includes a second developingstep 106, where a set of selection questions based on the set of initialdispensing criteria are developed.

Method 100 arranges the set of selection questions, during an arrangingstep 108, into a selection algorithm. Method 100 then includes a firstplacing step 110 where the medical product is placed in a vendingmachine and a second placing step 112 where the vending machine isplaced in a general sales location. Method 100 stores the selectionalgorithm on the controller at step 114. Finally, method 100, during adispensing step 116, controls the vending machine, via a controller, todispense a first sales unit of the particular medical product only if apurchaser successfully completes the selection algorithm via theinterface device 14.

In some embodiments, the purchaser may desire a second or subsequentsales unit of the medical product. Here, method 100 can includeprovisions for maintaining or allowing the medical product with thenon-prescription status for second or subsequent purchases by the samepurchaser.

In this embodiment illustrated in FIG. 7, method 100 further includes athird developing step 118, where a set of subsequent dispensing criteriaare developed. The set of subsequent dispensing criteria for theparticular medical product includes criteria sufficient to theresponsible regulatory agency, such as the FDA, to allow and or maintainthe status of the medical product at the non-prescription status. Next,method 100 includes a fourth developing step 120, where a set ofde-selection questions based on the set of subsequent dispensingcriteria are developed.

Method 100 arranges the set of de-selection questions, during a secondarranging step 122, into a de-selection algorithm. Method 100 stores thede-selection algorithm on the controller at step 124. Finally, method100, during a subsequent dispensing step 126, controls the vendingmachine, via the controller, to dispense a second or subsequent salesunit of the particular medical product only if a purchaser successfullycompletes the de-selection algorithm via the interface device 14.

In this manner, method 100 can advantageously facilitate switchingprescription medical products to non-prescription status in a way thatensures the criteria for obtaining the first and subsequent doses of themedical product are in compliance with the approved labeling bypreventing dispensing of the medical product in the event certainselection or de-selection criteria are not met.

It should be recognized that method 100 is described above by way ofexample only in use switching a medical product 20 d having aprescription status to a medical product 20 a having a non-prescription,over-the-counter status. Of course, it is contemplated by the presentdisclosure for method 100 to find equal use in switching a medicalproduct 20 c having a non-prescription, behind-the-counter status to amedical product 20 a having a non-prescription, over-the-counter status.

Referring now to FIG. 8, an exemplary embodiment of a method 150 for theuse of system 10 having selection and de-selection algorithms 24, 26 isshown.

Upon beginning the use of system 10 as shown in FIG. 8a , method 150 candetermine whether or not the purchaser is a first time purchaser at step152. If the purchaser is a first time purchaser, then method 150, atstep 154, can, in some embodiments, require the purchaser to enterpersonal identification information such as, but not limited to name,address, date of birth, e-mail address, telephone number, sex, allergyinformation, medications currently being used, and others. In thisembodiment, if the purchaser is a repeat purchaser, then method 150, atstep 156, requires the purchaser to enter enough information to allowthe system to access the purchaser's records stored on system 10. Onceretrieved, method 150 requires the purchaser to verify and updatepreviously entered enter personal identification information.

In other embodiments, system 10 may not required identification of thepurchaser via entry of personal information. Here, method 150 progressesdirectly to step 158 discussed below.

Next, the purchaser selects the desired medical product 20 to bepurchased at step 158 and requires the purchaser to verify the selectionat step 160. Upon verification of the desired product 20, method 150retrieves self-selection algorithm 24 and de-selection algorithm 26 forthe desired medical product 20.

In the illustrated example where the desired medical product 20 is acholesterol lowering medicine such as those available in the “statin”class of drugs, which are commercially available from the assignee ofthe present application, method 150 determines, at step 162, whether thepurchase request by the particular purchaser for that particular product20 is a first purchase request 164 or a second request 166. It should berecognized that in other examples of algorithms 24, 26 for other medicalproducts, method 150 may only need to differentiate first purchases fromsecond purchases, while still other algorithms 24, 26 for other medicalproducts may require method 150 to differentiate each purchase foranother.

When method 150 determines that the purchase request is the firstpurchase request 164, system 150 utilizes self-selection algorithm 24for the particular medical product 20 selected. In the illustratedexample, system 150 utilizes self-selection algorithm 24 for the medicalproduct.

Conversely, when method 150 determines that the purchase request is thesecond purchase request 166, system 150 utilizes a de-selectionalgorithm 26 for the particular medical product 20 selected, namely themedical product.

The self-selection and de-selection algorithms 24, 26 determine, basedon information entered/verified during steps 154, 156, whether thepurchaser is a male or a female at step 170. Based on the results ofdetermination step 170, method 150 continues to utilize the correctportion of self-selection and de-selection algorithms 24, 26,respectively.

When method 150 determines at step 170 (FIG. 8a ) that the purchaser isa first time purchaser of the particular medical product 20 and isfemale, method 150 continues to utilize the self-selection algorithm 24as show in FIG. 8b . Referring now to FIG. 8b , method 150, based oninformation entered/verified during steps 154, 156, determines whetherthe female purchaser is below the age of 55 and verifies this age withthe purchaser at step 172. If the purchaser is below the age of 55,namely is within the child bearing years, method 150 determines whetherthe purchaser is pregnant at step 174, and if not, whether the purchaseris incapable of becoming pregnant at step 176.

When method 150 determines at steps 172 (via age) and steps 174/176 thatthe female purchaser is not pregnant, the method requires the purchaserto input their cholesterol level at step 178. The cholesterol level canbe inputted at step 178 manually using data entry device 14-1, byconnecting a user supplied cholesterol measuring device to system 10, bymeasuring the level directly at system 10, or any other method discussedherein above.

After receiving the purchaser's cholesterol level, method 150, viaself-selection algorithm 24, compares this level to a predeterminedtherapy level at step 180. For example, if the purchaser's cholesterollevel is above the predetermined therapy level shown as above 170milligrams per deciliter (mg/dL), then method 150 continues to utilizethe self-selection algorithm 24 as show in FIG. 8 d.

However, if method 150 determines at any of steps 174, 176, or 180 thatthe medical product 20 is not appropriate for the purchaser, the methodnotifies the purchaser of this status at step 182 and terminates thepurchase request at step 184.

When method 150 determines at step 170 (FIG. 8a ) that the purchaser isa first time purchaser of the particular medical product 20 and is male,method 150 continues to utilize the self-selection algorithm 24 as showin FIG. 8c . Referring now to FIG. 8c , method 150, based on informationentered/verified during steps 154, 156, determines whether the malepurchaser is 45 years old or older and verifies this age with thepurchaser at step 186.

When method 150 determines at step 186 that the male purchaser is withinthe appropriate age bracket (i.e., 45 or older), the method requires thepurchaser to input their cholesterol level at step 188. Again, thecholesterol level can be inputted at step 178 by any method discussedherein above. After receiving the purchaser's cholesterol level, method150, via self-selection algorithm 24, compares this level to apredetermined therapy level at step 190. For example, if the purchaser'scholesterol level is above the predetermined therapy level shown asabove 170 mg/dL, then method 150 continues to utilize the self-selectionalgorithm 24 as show in FIG. 8 d.

However, if method 150 determines at either of steps 186 or 190 that themedical product 20 is not appropriate for the purchaser, the methodnotifies the purchaser of this status at step 192 and terminates thepurchase request at step 194.

When method 150 preliminarily determines that a particular purchaser isappropriate for the selected medical product 20 at step 180 (FIG. 8b )or step 190 (FIG. 8c ), the method continues to utilize self-selectioncriteria 24 to complete the analysis of the appropriateness of statintherapy for the purchaser as shown in FIG. 8d using a plurality of riskfactors 196.

Referring now to FIG. 8d , method 150 determines at step 198 whether thepurchaser is using any other cholesterol medications. Method 150 furtherdetermines whether the purchaser has liver disease at step 200 or hashad a prior adverse reaction to any statin medications at step 202.

If method 150 determines via steps 198, 200, 202, that the purchaserremains eligible for statin medication, then the method requestsinformation related to particular risk factors with the purchaser atstep 204 and then determines whether the number of risk factorsidentified at step 204 exceed at predetermined risk level at step 206.If purchaser remains eligible for statin medication after step 206,method 150 determines if the purchaser is taking a medication thatinteracts with statin medication at step 208. If, after completion ofstep 208, the purchaser remains eligible for statin medication, method150 proceeds to a dispensing step 216 shown in FIG. 8 e.

Referring to FIG. 8e , method 150, during dispensing step 216, requiresthe purchaser to acknowledge a plurality of warnings and instructionswith respect to the medical product 20. Method 150 verifies at step216-1 that each is acknowledged, and if so, dispenses the appropriateamount of the medical product 20 at step 216-2.

If method 150 determines via steps 198, 200, 202, that the purchaser ispreliminarily ineligible for statin medication, the method determines ifpurchaser discussed this situation with their doctor and receivedapproval none-the-less at step 210. If step 210 determines approval wasprovided, method 150 continues to step 206. However, if step 210determines approval was not provided, method 150 informs the purchaserthat medical product 20 is not appropriate for them at step 212 andterminates the purchase request at step 214.

Returning for a moment to FIG. 8a , when method 150 determines at step170 that the purchaser is a second time purchaser of the particularmedical product 20 and is female, method 150 continues to utilize thede-selection algorithm 26 as show in FIG. 8f . Referring now to FIG. 8f, method 150, based on information verified during steps 156, determineswhether the female purchaser is still below the age of 55 and verifiesthis age with the purchaser at step 272. If the purchaser is below theage of 55, namely is within the child bearing years, method 150determines whether the purchaser is pregnant at step 274, and if not,whether the purchaser is incapable of becoming pregnant at step 276.

When method 150 determines at steps 272 (via age) and steps 274/276 thatthe female purchaser is not pregnant, the method requires the purchaserto input their new cholesterol level at step 278, taken since thebeginning of therapy with statin medication. The cholesterol level canbe inputted at step 278 by any method discussed herein above.

After receiving the purchaser's cholesterol level, method 150, viade-selection algorithm 26, compares this level to a maximumpredetermined therapy level at step 280-1 and a minimum predeterminedtherapy level at step 280-2. For example, if the purchaser's cholesterollevel is within the therapy level of 130 mg/dL to 170 mg/dL, then method150 continues to utilize the de-selection algorithm 26 as show in FIG.8d and discussed above.

However, if method 150 determines at any of steps 274, 276, 280-1, or280-2 that the medical product 20 is not appropriate for the purchaser,the method notifies the purchaser of this status at step 282 andterminates the purchase request at step 284.

When method 150 determines at step 170 (FIG. 8a ) that the purchaser isa second time purchaser of the particular medical product 20 and ismale, method 150 continues to utilize the de-selection algorithm 26 asshow in FIG. 8g . Referring now to FIG. 8g , method 150, based oninformation verified during step 156, determines whether the malepurchaser is 45 years or older and verifies this age with the purchaserat step 286.

When method 150 determines at step 286 that the male purchaser is withinthe appropriate age bracket, the method requires the purchaser to inputtheir new cholesterol level at step 288, taken since the beginning oftherapy with statin medication. The cholesterol level can be inputted atstep 288 by any method discussed herein above.

After receiving the purchaser's cholesterol level, method 150, viade-selection algorithm 26, compares this level to a maximumpredetermined therapy level at step 290-1 and a minimum predeterminedtherapy level at step 290-2. For example, if the purchaser's cholesterollevel is within the therapy level of 130 mg/dL to 170 mg/dL, then method150 continues to utilize the de-selection algorithm 26 as show in FIG. 8d.

However, if method 150 determines at either of steps 286, 290-1, or290-2 that the medical product 20 is not appropriate for the purchaser,the method notifies the purchaser of this status at step 292 andterminates the purchase request at step 294.

When method 150 preliminarily determines that a particular purchaser isappropriate for the selected medical product 20 at step 280-2 (FIG. 8f )or step 290-2 (FIG. 8g ), the method continues to utilize de-selectionalgorithm 26 to complete the analysis of the appropriateness of statintherapy for the purchaser as shown in FIG. 8d using the plurality ofrisk factors 196.

In some embodiments, de-selection algorithm 26 determines whether thepurchaser has been taking the medical product in a prescribed dosage.For example, as a result of successful purchase of completion ofself-selection algorithm 24, system 10 may provide an amount of medicalproduct 20 that should last a predetermined period of time. Based on thedate of the subsequent attempt to purchase the same medical product 20,de-selection algorithm 26 can determine if the purchaser has not takenthe medication in the desired manner. Thus, system 10 can determine ifthe purchaser has returned for a subsequent purchase of the medicalproduct too soon, which may indicate taking too much of the medicalproduct. Alternately, system 10 can determine if the purchaser hasreturned for a subsequent purchase of the medical product too late,which may indicate taking not enough of the medical product.

Accordingly, and in this manner, system 10 can provide for interactivecompliance to the collateral measures necessary to meet the requirementsset forth by the FDA for switching such prescription medicines and/ortransferring restricted distribution status medical products to generalsales products.

In addition, system 10 can be configured to assist the purchaser inmatching an appropriate medical product 20 to symptoms or states of adisease currently being experienced by the purchaser. For example, andreferring again to FIG. 1, controller 16 can include a matchingalgorithm 32 resident thereon.

Matching algorithm 32 is configured to provide exemplary symptoms ordisease-states to the purchaser via data entry and communication device14-1 in a visual or auditory form. As used herein a “visual form” shallmean that the exemplary symptom or disease-state is provided to thepurchaser in non-textual form such as, but not limited to, a picture. Inthis manner, matching algorithm 32 allows the purchaser to match theirparticular symptom or disease state to the exemplary symptom ordisease-state presented. Once the purchaser identifies their symptom ordisease-state via matching algorithm 32, controller 16 provides thepurchaser with a list via device 14-1 of one or more medical products 20within vending machine 12 that are appropriate for that symptom ordisease-state.

Take for example a purchaser who has a cough and desires to purchase anon-prescription, over-the-counter cough medicine. System 10 determinesif the purchaser desires assistance, via matching algorithm 32, inselecting the appropriate medical product for their cough. Onceselected, matching algorithm 32 can present a plurality of differentauditory cough examples to the purchaser via data entry andcommunication device 14-1.

In this example, system 10 can ask the purchaser if their cough soundslike a loose or productive cough, and then play a sample loose coughrecording from a speaker 14-1 on vending machine 12. If the loose coughsample is not selected, then system 10 can ask the purchaser if theircough sounds like a dry or non-productive cough, and then play a sampledry cough recording from the speaker 14-1.

Matching algorithm 32 can continue to present exemplary symptoms ordisease-states to the purchaser until the purchaser identifies one thatmatches their particular condition. Upon selection of a particularsymptom or disease-state via matching algorithm 32, system 10 canprovide the purchaser with optional products 20 within vending machine12 that are appropriate for such symptoms or disease-states.

In some embodiments, matching algorithm 32 can only present thosemedical products 20 that do not have adverse interactions with medicalproducts currently being used by the purchaser or medical conditions(e.g., high blood pressure) experienced by the purchaser.

However, matching algorithm 32 can also prompt the user to see a medicalprofessional or doctor in the event that no matching symptom ordisease-state is selected, in the event that no medical product 20 isavailable to the purchaser due to other factors (e.g., age, sex,potential for drug interaction, and warnings such as allergy, etc), andany combinations thereof.

It should be recognized that matching algorithm 32 is described above byway of example using auditory symptom or disease-state matching. Ofcourse, it is also contemplated by the present disclosure for matchingalgorithm 32 to provide visual symptom or disease-state matching suchas, for example, providing non-textual visual examples of a conditionsuch as, but not limited to, a skin rash that requires treatment.

It should also be recognized that matching algorithm 32 is describedabove by way of example in use with medical products 20 a withoutdistribution restrictions. However, it is contemplated by the presentdisclosure for matching algorithm 32 to find use with any medicalproduct 20, namely those without any distribution restrictions (i.e.,products 20 a) and those with distribution restrictions (i.e., products20 b, 20 c, 20 d).

In some embodiments, it is contemplated by the present disclosure forsystem 10 to be configured for distribution of one particular medicalproduct. Here, system 10 can have matching algorithm 32 for only thatparticular medical product. In use, the purchaser would use system 10for the particular medical product they are interested in purchasing byapproaching the system advertised for that particular medical product.Then, controller 16 resident on system 10 can allowing the purchaser toaccess to matching algorithm 32 and provide a plurality of exemplarysymptoms or disease-states for the particular medical product to thepurchaser via the data entry and communication devices 14. In thismanner, the purchaser can select one or more symptoms or disease-statesfrom the plurality of exemplary symptoms or disease-states when the oneor more symptoms or disease-states match those currently beingexperienced by the purchaser. Once a symptom or disease-state that thepurchaser is experiencing has been selected from the matching algorithm32, system 10 can operate in the manner discussed herein above. Moreparticularly, system 10 can initiate the use of the select and/orde-selection algorithms 24, 26, respectively.

Referring to the drawings and in particular to FIG. 9, an alternateexemplary embodiment of a medical product dispensing system 310 isshown. For purposes of clarity, a detailed description of componentparts in system 310 that perform a similar and/or analogous function asthose discussed above with respect to system 10 has been omitted.

Advantageously, system 310 is configured for use in the dispensing ofmedical products 20 b, 20 c, and 20 d, which have restricteddistribution requirements, without the need for interaction between thepurchaser and a licensed practitioner. Further, system 310 is configuredfor use in the dispensing of medical products 20 a, which do not havedistribution restriction imposed by one or more regulating bodies, butrather by the retailer and/or product manufacturer. In one embodiment,system 310 provides the purchaser with a printed ticket or transactionrecord 340, which can be presented to a sales associate, pharmacist orpharmacy personnel located at the point-of-sale. Here, the personnel canretrieve the medical product from a secure location based on the printedticket or transaction record (hereinafter “record”) and complete thetransaction. The transaction record 340 can be representative of themedical product or, in some embodiments, can be a proof of purchase ofthat medical product via system 310. In other embodiments, thetransaction record 340 can be the equivalent of a medical questionnairesuch as that typically used in the United Kingdom and required by thepharmacist for purchase of behind-the-counter medical products 20 c.

Thus, record 340 can be a coupon allowing the holder to purchase themedical product identified on the record. Alternately, system 310 can,upon successful completion of the selection process or de-selectionprocess, require the user to provide electronic payment for the productsuch that the record 310 is also a receipt for the purchase of theproduct.

Thus, system 310 provides the purchaser with a printed ticket ortransaction record 340, which can be presented to a sales associate,pharmacist or pharmacy personnel located at the point-of-sale along withthe medical product itself. Here, the purchaser can retrieve the medicalproduct from a typical store location, present the product and therecord to the sales associate at the point-of-sale for completion of thetransaction.

In embodiments where record 340 is the coupon allowing the holder topurchase the medical product identified on the record, it iscontemplated for the sales associate to be prevented from completing thesales transaction of the medical product without the associated record340. For example, the associate can be trained to not completetransactions for certain products without the associated record 340. Inother examples, the point-of-sale system (not shown) such as the cashregister can be configured to prevent transactions for certain productswithout the associated record 340.

System 310 provides an effective guide to the purchaser through a seriesof medical history and/or medical product related questions, and alsoprovides product specific information of interest and importance to theinformation to the purchaser.

Thus, system 310, much like system 10 discussed above, provides anelectronic device to significantly reduce the time with or replace alearned intermediary (i.e., licensed practitioner) by capturing thecritical elements that a learned intermediary provides, and alsoprovides effective collateral methods for the safe and effective use ofa prescription or restricted access medical product in an over thecounter environment. Further, system 310 can also be used to helpfacilitate the purchase of a medical product from a behind-the-counterenvironment such as that used in the United Kingdom and/or to facilitatethe purchase of Schedule 3 and 4 medical products such as those inAustralia.

More particularly, system 310 provides an interactive computer havingaccess to one or more of the product specific self-selection algorithm24, the product specific de-selection algorithm 26, the matchingalgorithm 32, and any combinations thereof.

However, instead of dispensing the medical products 20 a, 20 b, 20 c,and 20 d directly from system 310 as with system 10, system 310 isconfigured to dispense a record 340 for the medical product selected bya purchaser. Here, system 310 dispenses the record 340 only if thepurchaser qualifies for the medical product medical products 20 a, 20 b,20 c, and 20 d as determined by the product specific self-selectionalgorithm 24, or limits by the label, manufacturer, retailer or othergovernmental agencies.

Upon subsequent requests for the particular medical product 20 a, 20 b,20 c, and 20 d, the system 310 can dispense a subsequent record 340 forthe particular medical product if the purchaser remains qualified forthe medical product as determined by the de-selection algorithm 26 inaccordance with the prior and new information inputted by the purchaser,or limitations as specified by the label, manufacturer, retailer orother governmental agencies.

Record 340 includes data 342 printed or otherwise recorded thereon. Data342 can include information such as but not limited to customer identityinformation, a sales receipt, a product description, a product picture,a purchaser picture, and other data related to the customer, the medicalproduct, or the transaction.

As shown in FIG. 9, system 310 includes a record generating machine 312having one or more person-machine-interface devices 314. System 310 alsoincludes a controller 16 in communication with record generating machine312 and one or more interface devices 14-1, 14-2, 14-3, and 14-4.

Record generating machine 312 can also include a printer or encoder 314and/or can be in electrical communication with the printer or encoder314 for providing record 340.

In the illustrated embodiment of system 310, controller 16 is shownbeing remote from record generating machine 312 and communicating withone another via a network 22. However, it is also contemplated by thepresent disclosure for controller 16 to be resident in record generatingmachine 312. Moreover, it is contemplated for system 10 to include twocontrollers, one resident in record generating machine 312 and oneremote from the record generating machine 312, where the two controllerscommunicate over network 22. Network 22 can be any desired communicationnetwork such as, but not limited to, a wide-area-network, the Internet,and others.

For example, and with reference to FIG. 10, it is contemplated by thepresent disclosure for record generating machine 312 to be a personalcomputer 350 communicating with controller 16 over the internet 22.Here, personal computer 350 can be located at the point-of-sale or canbe located at the purchasers home, place of business, and the like.Thus, system 310 allows a purchaser to access controller 16 from anydesired location via the Internet and after successful interaction withone or more algorithms 24, 26, 32, allows the purchaser to print out therecord 340 via a printer (not shown) that reports that the purchaser iseligible and that medical product is acceptable for use. The purchaserthen takes the record 340 to a store to purchase the medical product bypresenting the record 340 to the store's staff. The presentation of therecord 340 to the store's staff can be completed simultaneously to thepresentation of the desired product, which the purchaser has retrievedfrom the store's retail space. Alternately, the record 340 can bepresented to the store's staff where upon the staff can retrieve thedesired product from a secure location.

System 310 finds use with any of the methods 40, 60, 80, 100, and 150discussed herein above. However, instead of dispensing the medicalproduct, system 310 generates record 340. Once record 340 has beengenerated, the purchaser can present the record a sales associatelocated at the point-of-sale.

Yet another embodiment of a medical product dispensing system 410contemplated by the present disclosure is shown in FIG. 11. Here, theconsumer “communicates with” or “accesses” controller 16 via a telephone452. In some embodiments, the consumer communicates with controller 16directly via an electronic telephone user interface. In otherembodiments, the consumer communicates indirectly with controller 16 viaa customer service representative, who in-turn communicates with thecontroller via a computer 450.

Instead of providing a record of the transaction to the purchaser, asdescribed in the embodiments above, the medical product dispensingsystem 410 mails the purchased product directly to the consumer. Thus,system 410 allows a purchaser to access controller 16 from any desiredlocation and after successful interaction with one or more algorithms24, 26, 32, allows the purchaser to receive the desired medical productonly if that purchaser is eligible and the medical product is acceptablefor use.

System 410 finds use with any of the methods 40, 60, 80, 100, and 150discussed herein above. However, instead of dispensing the medicalproduct, system 410 results in the desired medical product beingdelivered directly to the purchaser via the mail.

In some embodiments, systems 10, 310, and/or 410 can be configured toensure compliance with Federal and/or State controlled distributionrequirements for medical products 20 b such as but not limited to PSEcontaining products and others. For example, systems 10, 310, and/or 410can be configured to print and/or report sales transactions to theresponsible agency. Systems 10, 310, and/or 410 can be configured totransmit a sales record to another location such as the aforementionedagency that would allow for verification of user and product selectedand amount at the point-of-sale. Systems 10, 310, and/or 410 can beconfigured to collect and report information on particular purchasers'purchasing records for drug products that have potential abuseliabilities. The documentation may include quantities of product sold,date sold and total number of products sold.

It should also be noted that the terms “first”, “second”, “third”,“upper”, “lower”, and the like may be used herein to modify variouselements. These modifiers do not imply a spatial, sequential, orhierarchical order to the modified elements unless specifically stated.

While the present disclosure has been described with reference to one ormore exemplary embodiments, it will be understood by those skilled inthe art that various changes may be made and equivalents may besubstituted for elements thereof without departing from the scope of thepresent disclosure. In addition, many modifications may be made to adapta particular situation or material to the teachings of the disclosurewithout departing from the scope thereof. Therefore, it is intended thatthe present disclosure not be limited to the particular embodiment(s)disclosed as the best mode contemplated, but that the disclosure willinclude all embodiments falling within the scope of the appended claims.

What is claimed is:
 1. A system for dispensing a restricted distributionmedical product comprising: a controller comprising a processor and amemory; a vending machine having a person-machine interface device incommunication with the controller, wherein the person-machine interfaceaccepts input of information from a potential purchaser including theidentity of a restricted distribution medical product requested by thepotential purchaser and information relating to the potentialpurchaser's medical condition; a supply of the requested restricteddistribution medical product stored in the vending machine, wherein therestricted distribution medical product is selected from the groupconsisting of a medicine typically requiring physician involvement, anda medicine that has an illicit alternative use from the use typical forthe medicine or combination thereof; an electronic self-selectionalgorithm stored on the controller, wherein the controller via theelectronic self-selection algorithm requires the potential purchaser toenter information into the person-machine interface concerning thepotential purchaser's medical condition including information relevantto the requested restricted distribution medical product to complete theelectronic self-selection algorithm, wherein, for a first request forthe distribution restricted medical product having approved labelinginformation identified by a governmental agency and associated with thedistribution restricted medical product, the approved label informationincluding risks associated with use of the restricted distributionmedical product, the electronic self-selection algorithm (a) evaluates(1) the information identified by a governmental agency and included onthe approved labeling of the requested restricted distribution medicalproduct and (2) the information provided by the potential purchaser intothe person-machine interface relating to the potential purchaser'smedical condition including information relevant to the requestedrestricted distribution medical product, and (b) based on theevaluation, determines whether there is a benefit of starting treatmentwith the restricted distribution medical product and whether the benefitoutweighs the risk associated with not starting treatment, wherein thecontroller (c) controls the vending machine to dispense a first salesunit of the requested restricted distribution medical product, andwherein (a), (b) and (c) are performed without involvement of anylicensed practitioner or a prescription, when the benefit outweighs therisk associated with not starting treatment.
 2. The system according toclaim 1 further comprising: an electronic de-selection algorithm storedon the controller, wherein the controller via the electronicde-selection algorithm requires the potential purchaser to enter updatedinformation relating to the potential purchaser's medical conditionincluding updated information relevant to the requested restricteddistribution medical product into the person-machine interface tocomplete the electronic de-selection algorithm, wherein, for asubsequent request for the distribution restricted medical product, theelectronic de-selection algorithm (a1) evaluates (1) the updatedinformation provided by the potential purchaser into the person-machineinterface relating to the potential purchaser's medical conditionupdated to the time of the subsequent request including the updatedinformation relevant to the requested restricted distribution medicalproduct and (2) past use of the restricted distribution medical product,and (b1) based on the evaluation, determines whether there is a benefitto continue treatment with the requested restricted distribution medicalproduct and whether the benefit outweighs the risk associated with notcontinuing treatment, wherein the controller (c1) controls the vendingmachine to dispense a subsequent sales unit of the requested restricteddistribution medical product, and wherein (a1), (b1) and (c1) areperformed without involvement of any licensed practitioner or aprescription, when the benefit outweighs the risk associated with notcontinuing treatment.
 3. The system according to claim 1, wherein thecontroller via the electronic self-selection algorithm further requiresthe potential purchaser to enter biometric data of the potentialpurchaser relevant to the requested restricted distribution medicalproduct to complete the electronic self-selection algorithm further anddetermines whether to dispense the first sale of the requestedrestricted distribution medical product based on, at least in part, thebiometric data.
 4. The system according to claim 3, wherein thecontroller via the electronic de-selection algorithm further requiresthe potential purchaser to enter updated biometric data of the potentialpurchaser including the updated information relevant to the requestedrestricted distribution medical product to complete the electronicde-selection algorithm and determines whether to dispense the subsequentsales unit of the requested restricted distribution medical productbased on, at least in part, the updated biometric data.
 5. The systemaccording to claim 2, wherein the person-machine interface accepts inputof information from a potential purchaser via telephone including (a)the identity of a restricted distribution medical product requested bythe potential purchaser and information relating to the potentialpurchaser's location, identity and medical condition, (b) input ofinformation from the potential purchaser including information relevantto the requested restricted distribution medical product required by thecontroller via the electronic self-selection algorithm to complete theelectronic self-selection algorithm and/or (c) input of information fromthe potential purchaser including updated information relevant to therequested restricted distribution medical product required by thecontroller via the electronic self-selection algorithm to complete theelectronic de-selection algorithm.
 6. A system for dispensing arestricted distribution medical product comprising: a controllercomprising a processor and a memory; a vending machine in a generalsales location, the vending machine having a person-machine interfacedevice in communication with the controller, wherein the person-machineinterface accepts input of information from a potential purchaserincluding the identity of a restricted distribution medical productrequested by the potential purchaser and information relating to thepotential purchaser's medical condition including information relevantto the requested restricted distribution medical product, wherein therestricted distribution medical product comprises a medicine typicallyrequiring physician involvement or a medicine that has an illicitalternative use from the use typical for the medicine; an electronicself-selection algorithm stored on the controller, wherein thecontroller via the electronic self-selection algorithm requires thepotential purchaser to enter information concerning the potentialpurchaser's medical condition including the information relevant to therequested restricted distribution medical product into theperson-machine interface to complete the electronic self-selectionalgorithm, wherein, for a first request for the distribution restrictedmedical product having approved labeling information identified by agovernmental agency and associated with the distribution restrictedmedical product, the approved labeling information including risksassociated with use of the restricted distribution medical product, theelectronic self-selection algorithm (a) evaluates (1) the informationidentified by a governmental agency and included on the approvedlabeling of the requested restricted distribution medical product and(2) the information provided by the potential purchaser into theperson-machine interface relating to the potential purchaser's medicalcondition including the information relevant to the requested restricteddistribution medical product, and (b) based on the evaluation,determines whether there is a benefit of starting treatment with therestricted distribution medical product and whether the benefitoutweighs the risk associated with not starting treatment, and whereinthe controller (c) controls the vending machine to dispense atransaction record for a first sales unit of the requested restricteddistribution medical product, wherein (a), (b) and (c) are performedwithout involvement of ay licensed practitioner or a prescription, whenthe benefit outweighs the risk associated with not starting treatment.7. The system according to claim 6, further comprising: an electronicde-selection algorithm stored on the controller, wherein the controllervia the electronic de-selection algorithm requires the potentialpurchaser to enter updated information concerning the potentialpurchaser's medical condition including updated information relevant tothe requested restricted distribution medical product into theperson-machine interface to complete the electronic de-selectionalgorithm, wherein, for a second or subsequent request for thedistribution restricted medical product, the electronic de-selectionalgorithm (a1) evaluates (1) the updated information provided by thepotential purchaser into the person-machine interface relating to thepotential purchaser's medical condition including the updatedinformation relevant to the requested restricted distribution medicalproduct updated to the time of the second or subsequent request and (2)past use of the restricted distribution medical product, and (b1) basedon the evaluation, determines whether there is a benefit to continuetreatment with the requested restricted distribution medical product andwhether the benefit outweighs the risk associated with not continuingtreatment, wherein the controller (c1) controls the vending machine todispense a transaction record for the subsequent sales unit of therequested restricted distribution medical, and wherein (a1), (b1) and(c1) are performed without involvement of any licensed practitioner or aprescription, when the benefit outweighs the risk associated with notcontinuing treatment.
 8. The system according to claim 7, wherein eitheror both of the selection algorithm and the de-selection algorithm can beaccessed from a remote location via an internet connection and thetransaction record can be printed out at the remote location.
 9. Amedical product distribution apparatus comprising: a vending machinecontaining a supply of a restricted distribution medical product storedtherein, wherein the restricted distribution medical product comprises amedicine typically requiring physician involvement or a medicine thathas an illicit alternative use from the use typical for the medicine; aperson-machine interface in communication with the vending machine; anda controller comprising a processor and a memory containing (a) analgorithm, (b) stored approved labeling information identified by agovernmental agency and relating to the restricted distribution medicalproduct, wherein the stored approved labeling information identified bya governmental agency includes risks associated with use of therestricted distribution medical product, and (c) instructions that arereadable by the controller and cause the controller to: (1) require apotential purchaser of a restricted distribution medical product toenter information relating to the potential purchaser's medicalcondition including information relevant to the requested restricteddistribution medical product into the person-machine interface; (2)cause the algorithm to: compare (i) the entered information relating tothe potential purchaser's medical condition including the informationrelevant to the requested restricted distribution medical product and(ii) the stored approved labeling information; determine whether thereis a benefit of treatment of the potential purchaser with the restricteddistribution medical product; and determine whether the benefitoutweighs risks to the potential purchaser associated with treatmentusing the restricted distribution medical product; and (3) cause thevending machine to dispense the restricted distribution medical productto the potential purchaser, wherein the comparing and determining ofstep (2) are performed without involvement of any licensed practitioneror a prescription, when the benefit outweighs the risks associated withtreatment using the restricted distribution medical product.
 10. Anon-transitory storage medium comprising: an algorithm; informationidentified by a governmental agency relating to a restricteddistribution medical product included on an approved labeling of therestricted distribution medical product, wherein the restricteddistribution medical product comprises a medicine typically requiringphysician involvement or a medicine that has an illicit alternative usefrom the use typical for the medicine; and instructions that arereadable by a controller comprising a processor and a memory of avending machine having a person-machine interface and containing asupply of the restricted distribution medical product, and cause thecontroller to perform the following steps: (1) require a potentialpurchaser of the restricted distribution medical product to enterinformation relating to the potential purchaser's medical conditionincluding information relevant to the requested restricted distributionmedical product into the person-machine interface; (2) cause thealgorithm to: compare the (i) entered information relating to thepotential purchaser's medical condition including the informationrelevant to the requested restricted distribution medical product and(ii) the stored information, wherein the stored information alsoincludes risks associated with use of the restricted distributionmedical product; determine whether there is a benefit of treatment ofthe potential purchaser with the restricted distribution medicalproduct; and determine whether the benefit outweighs risks to thepotential purchaser associated with treatment using the restricteddistribution medical product; and (3) dispense the restricteddistribution medical product to the potential purchaser from the vendingmachine, wherein the comparing and determining of step (2) are performedwithout involvement of any licensed practitioner or a prescription, whenthe benefit outweighs the risks associated with treatment using therestricted distribution medical product.